Switching from tenofovir disoproxil fumarate to bictegravir/emtricitabine/ tenofovir alafenamide or non-tenofovir alafenamide regimens: a real-world study of safety and efficacy in Chinese people living with HIV.

BACKGROUND

Tenofovir disoproxil fumarate (TDF) carries bone and renal toxicity risks. Data are limited on Chinese people living with HIV (PLWH) switching from TDF-based regimens to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and non-BIC/FTC/TAF.

RESEARCH DESIGN AND

METHODS

This retrospective cohort study enrolled virologically-suppressed PLWH receiving TDF (>48 weeks) at PUMCH (2014-2025). We analyzed efficacy/safety at 96 weeks post-switch to BIC/FTC/TAF or non-BIC/FTC/TAF. Primary endpoints: viral suppression, immune recovery, and safety [bone mineral density(BMD)/eGFR/weight/serum lipids], assessed from 48 weeks pre-switch to 96 weeks post-switch.

RESULTS

After screening, 169 of 1,592 PLWH were enrolled (mean age 41 years; 89.3% male; mean TDF duration 67.8 month): 111 switched to BIC/FTC/TAF, 58 to non-BIC/FTC/TAF (25 dolutegravir-based). All BIC/FTC/TAF recipients maintained virologic suppression but one low-level viremia in non-BIC/FTC/TAF, CD4+ T-cell increased similarly (p > 0.05). Pre-switch (48-week on TDF) BMD decreased (spine/hip/femoral neck: -1.78%/-3.03%/-2.39%); At week 96 post-switch, BMD increased (BIC/FTC/TAF: +3.55%/+2.52%/+3.48%; non-BIC/FTC/TAF: +2.18%/+2.19%/+2.8%; p > 0.05). Pre-switch eGFR similarly decreased: -9 mL/min/1.73 m2, post-switch increased (BIC/FTC/TAF +3.6 vs non-BIC/FTC/TAF +5.1, p > 0.05). Pre-switch slight weight gain (+0.27 kg), post-switch: BIC/FTC/TAF (+1.59 kg), dolutegravir (DTG)-based (+3.54 kg), non-DTG/BIC (+0.95 kg). Serum lipids increased in all groups (p > 0.05).

CONCLUSIONS

Switching from TDF to BIC/FTC/TAF or Non-BIC/FTC/TAF was associated with improved bone/renal safety with maintained efficacy in Chinese PLWH. But integrase strand transfer inhibitor(INSTI)-based regimens necessitate monitoring for weight and lipid changes. These findings warrant confirmation in larger studies.